BiocompCHATibility

In this episode of NAMSA’s BiocompCHATibility Podcast, our hosts discuss early feasibility studies and the scope of biocompatibility necessary to get started. They highlight the importance of controlling device response in a small patient group and how this approach shapes biocompatibility considerations within the framework of risk management. “The control measure of just having a few patients is...

n this episode of NAMSA’s BiocompCHATibility podcast, we welcome back Dr. Phil Smiraldo (Principal Toxicologist, NAMSA) for his third appearance as an honorary host. The discussion centers on the complexities of equivalency in biocompatibility, examining how equivalency can range from simple to complex and how a predicate device does not always equal equivalency. Listen in as we explore these topi...

In this episode, our hosts are joined by Charles Ducker, PhD (NAMSA's Senior Director of Analytical Services) who recently returned from Korea, where he provided training to the MFDS (Ministry of Food and Drug Safety) about ISO 10993-18. Throughout this discussion, we review the use of the standard and how it is adopted by Korean authorities. We also explore the challenges that lie ahead for devic...

On the latest installment of the BiocompCHATibility podcastis episode, our hosts are joined by Dr. Phil Smiraldo for his third feature3-peat episode on the podcast. The conversation throughout this episode focuses and we discuss on the new recently published FDA biocompatibility guidance document —issued onn September 7, 2023. “My favorite nuance is that annex A has slightly been updated because n...

In this first BiocompCHATibility Podcast episode of 2023, our hosts are happy to introduce a new podcast to the NAMSA family, and talk a little bit to the hosts about the insightful topics to come. This new, conversational podcast will feature a new set of hosts who dedicate each episode to trending regulatory and quality affairs topics within the MedTech industry. Future topics include: Refuse to...

In this episode, Dr. Phil Smiraldo (NAMSA’s Senior Toxicologist) joins us to discuss the test article and the many challenges with identification and preparation. Throughout this discussion, we explore the many different types of test articles and help define what is considered patient contact and what is not? We also review how you can best work with your laboratory to define your test article pr...

In this episode, our hosts are joined by NAMSA Associate, Dr. Darin Kent, and second-time guest, Dr Ted Heise, to discuss the new paper released by the FDA and the American Chemical Society. The intention of this latest FDA publication is to examine specific topics that promote continuous discussion around the disparities between where the industry currently stands and how alignment and proper dev...

In this episode, NAMSA’s Senior Product Development Specialist, Ed Arscott, joins our hosts to examine the relationship between packaging and biocompatibility, including: how to evaluate primary packaging for biological safety. The discussion also focuses on the direction provided in ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials. Listeners can e...

In this episode, our hosts are joined by NAMSA Toxicologist, Michelle Kelly, to discuss the ever-elusive biological equivalency claim. The discussion focuses on how to maintain the balance of the risk and benefit of a medical device without stalling innovation. We also explore equivalency and how it is not only a key concept to the risk analysis but also a challenging concept to prove. “This...

In this episode, our hosts are joined by the QB1 (or 4 of them) of GLP (Good Laboratory Practice), NAMSA’s Study Directors. Throughout this podcast, the team delves into the role of the Study Director in biocompatibility and chemical characterization studies, discussing day-to-day activities, legalities, key factors manufacturers should know about working with a Study Director, and the qualificati...

In its third year, the North American Biocompatibility Summit (NABS) is a limited-seating event that provides industry insights and expertise sharing on the biocompatibility of medical devices. This year, sessions will include the latest regulatory updates, biological evaluation strategies, and best practices that lead to successful biocompatibility programs in 2021 and beyond.  In this episo...

NAMSA is pleased to announce that the U.S. Food and Drug Administration (FDA) granted the organization Accreditation Scheme for Conformity Assessment (ASCA) status on July 23. The ASCA Pilot Program, a first-of-its-kind assessment created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency. In this...

Over the last year, the BiocompCHATibility Podcast hosts have been compiling questions asked by our listeners and training series attendees. In this episode, we will answer your frequently asked questions about all things biocompatibility—and no, we did not answer why Don is funnier than Sheri (it is definitely a growth opportunity for her). Highlights include: The use of clinical data in the biol...

In this episode, our hosts are joined by APS’s Senior Director of Biocompatibility Services, Dr. Yan Chen, to discuss NAMSA’s acquisition of APS and the importance of preclinical studies in the biological evaluation of medical devices. This podcast discussion revolves around the many synergies of the combined companies, as well as a technical discussion regarding preclinical studies, preclinical s...

In this episode, our hosts answer listener questions regarding the new ISO 10993-23:2021 from NAMSA’s February 3, 2021 webinar. The standard recommends that In Vitro testing be completed prior to In Vivo testing, warranting many questions about how to deal with legacy data, regulatory acceptance and timelines. Our hosts will provide podcasters a full episode of responses, possible scenarios and po...

In this episode, our guests are joined by Syntactx’s Dr. Valerie Merkle, Associate Director – Regulatory Strategy, to discuss NAMSA’s recent acquisition of Syntactx. During this one-hour installment, Dr. Merkle discusses her deep-rooted experience at the FDA and the importance of proper biological safety planning to achieve biomechanical efficiency and successful clinical trial execution. Examples...

In this episode, our guests are joined my NAMSA’s Melissa Cadaret to discuss the ever-confusing cytotoxicity failure.  Manufacturers can have more questions created when encountering an unexpected cytotoxicity result and these podcast experts have seen thousands of various cytotoxicity results.  The information provided from a cytotoxicity test can be useful and stressful, so what do man...

In this episode, our hosts are joined by Allison C. Komiyama, Ph. D., R.A.C., Owner and Consultant at AcKnowledge Regulatory Strategies and former U.S. FDA reviewer, to discuss the U.S. FDA’s latest draft guidance, “Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.”  The FDA has determined the biocompatibility risk of various polymers and fabrics to be low ba...

In this episode, our hosts are joined by Lisa Olson (NAMSA’s Vice President, North American Lab Services) to discuss the U.S. FDA’s new Accreditation Scheme for Conformity Assessment (ASCA). This pilot program, launched September 24, 2020 with a new guidance document , is designed to accredit laboratories for certain biocompatibility tests, allowing for decreased paperwork and time for certain reg...

In this episode, our hosts are joined by Dr. Joe Carraway, co-author of the new research paper, “ The suitability of reconstructed human epidermis models for medical device irritation assessment: A comparison of In Vitro and In Vivo testing results,” which discusses in vitro irritation assays and their viability for medical device testing. The three Rs in this type of experimentation, which s...

In this episode, two esteemed colleagues from Abbott, Tim Schatz and Ken Grove, join our hosts discuss ISO 10993-4:2017 Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood. Our experts highlight the general requirements of this very important and sometimes misunderstood segment of biological evaluations, including how to classify products requiring thi...

In this bonus episode, our hosts discuss the new FDA Supplementary Information Sheet (SIS) on ISO 10993-18:2020 and their extent of recognition. On July 6, 2020 the FDA released this document to help clarify how manufacturer’s should utilize ISO 10993-18:2020 for US submissions. With this release, may come more questions than answers, so we decided to try to clarify this document and highlight the...

In this episode, our hosts answer your questions about biocompatibility. After 15 episodes of discussing what we think is important surrounding this topic, we asked for your questions and created this special episode to answer them. “A toxicological risk assessment is the process of focusing on the risk associated with the chemicals that are in or may come out of a device, that’s your primary focu...

In this episode, our hosts are joined by Nicole Soucy, PhD, DABT from Boston Scientific to discuss qualifications of expert assessors and other personnel qualified to make biological evaluation decisions for medical devices. Documents including ISO 10993-1, Medical Device Regulation (MDR) documentation submissions and BSI best practice guidelines recommend having a qualified individual make decisi...

In this episode our hosts are joined by 2 esteemed colleagues from Abbott: Deanna Porter, Kent Grove to discuss the US FDA pre-sub meeting process as it pertains to the biocompatibility of Medical devices. The group will review the current procedure for a pre-sub meeting and how this opportunity to obtain FDA feedback prior to an intended submission can be very useful, especially for programs cont...